# US 10,245,364 B2 · Safety apparatus for extracorporeal blood treatment

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- Number: US 10,245,364 B2
- Document ID: US10245364B2
- Status: Granted
- Kind: B2
- Application number: 14/394,949
- Filed: 2013-04-15
- Published: 2015-05-07
- Granted: 2019-04-02
- Earliest claimed: 2012-04-16
- Assignees: Fresenius Medical Care Deutschland GmbH
- Applicants: Fresenius Medical Care Deutschland GmbH
- Inventors: Martin Brandl; Dieter Falkenhagen; Jens Hartmann
- Web page: https://patentgrep.com/patent/US10245364B2

## CPC

- A61M 1/16: with membranes
- A61M 1/1603: {Regulation parameters}
- A61M 1/1609: {after use, i.e. downstream of dialyser}
- A61M 1/361: {before treatment}
- A61M 1/3612: {after treatment}
- A61M 1/3621: {Extra-corporeal blood circuits (single-needle circuits A61M1/30)}
- A61M 1/3672: {Means preventing coagulation}
- A61M 1/3675: {Deactivation}
- B01D 61/30: Accessories; Auxiliary operation
- B01D 61/32: Controlling or regulating
- A61M 2205/18: with alarm
- A61M 2205/3324: PH measuring means
- A61M 2230/202: partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
- A61M 2230/208: pH-value
- F04C 2270/0421: Controlled or regulated
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- F04C: ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS (engines F03C); ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS

## Abstract

Blood purification device having an extracorporeal blood circuit with a blood inflow and outflow to and from a dialysis unit, wherein the dialysis unit comprises a dialysis solution inflow and a dialysate outflow, characterized by a control loop for control of the acid-base equilibrium of the blood, wherein bicarbonate is supplied to the blood using an aqueous bicarbonate-containing solution, wherein a measuring means for measuring a blood buffer parameter is associated with the control loop, wherein the blood buffer parameter is selected from one of bicarbonate concentration and CO2 partial pressure, and wherein a signal corresponding to the measured value of the blood buffer parameter can be supplied to a closed-loop control apparatus, which regulates the value of the blood buffer parameter by the supply of bicarbonate, and at least one pH-measuring means, wherein a signal corresponding to the pH value can be supplied to an alarm apparatus.

## Claims

### Claim 1

A blood purification device comprising:
an extracorporeal blood circuit with a blood inflow to a dialysis unit for blood removed from a patient and a blood outflow from the dialysis unit for blood being guided back into the patient, wherein the dialysis unit comprises an inflow for a dialysis solution and a dialysate outflow,
a citrate anticoagulation apparatus, wherein citrate is supplied to the extracorporeal blood circuit at a citrate supply point upstream of the dialysis unit and a substitute medium dosing apparatus, wherein substitution medium is supplied at a substitution medium supply point downstream of the dialysis unit,
a control loop for controlling the acid-base balance of the blood, wherein bicarbonate is supplied to the blood by means of an aqueous bicarbonate-containing solution, wherein at least one measuring means for measuring a blood buffer parameter is associated with the control loop and upstream of the citrate supply point in the extracorporeal blood circuit, wherein the blood buffer parameter is selected from the group consisting of bicarbonate concentration and CO2 partial pressure, and wherein a signal corresponding to the measured actual value of the blood buffer parameter can be supplied to a control apparatus, which regulates the actual value of the blood buffer parameter via the supply of bicarbonate to a predeterminable intended value or intended value range,
at least one pH-measuring means, which is arranged upstream of the citrate supply point in the extracorporeal blood circuit, wherein a signal corresponding to the pH value can be supplied to an alarm apparatus, which triggers an alarm signal if a predeterminable pH value or a pH-value range is exceeded or undershot,
wherein the arrangement of the at least one measuring means for measuring a blood buffer parameter located upstream of the citrate supply point in the extracorporeal blood circuit and the at least one pH-measuring arranged upstream of the citrate supply point are configured to detect and prevent or treat disturbances of the acid-base balance during an extracorporeal blood purification selected from the group of compensated acidosis, non-compensated acidosis, compensated alkalosis and compensated or non-compensated alkalosis,
at least one additional measuring means for measuring a blood buffer parameter that is associated with the control loop and arranged downstream of the dialysis unit and upstream of the substitution medium supply point in the extracorporeal blood circuit, and
at least one additional pH-measuring means that is arranged downstream of the substitution medium supply point in the extracorporeal blood circuit, wherein a signal corresponding to the pH value can be supplied to the alarm apparatus, which triggers an alarm signal if a predeterminable pH value or pH-value range is exceeded or undershot.

### Claim 2 (depends on 1)

The blood purification device according to claim 1, wherein the aqueous bicarbonate-containing solution is a dialysis solution.

### Claim 3 (depends on 1)

The blood purification device according to claim 1, wherein the aqueous bicarbonate-containing solution is an infusion solution.

### Claim 4 (depends on 1)

The blood purification device according to claim 1, wherein at least one additional measuring means for measuring a blood buffer parameter is comprised within the control loop and is arranged upstream of the dialysis unit in the extracorporeal blood circuit.

### Claim 5 (depends on 1)

The blood purification device according to claim 1, wherein at least one additional measuring means for measuring a blood buffer parameter is comprised within the control loop and is arranged upstream of the citrate supply point in the extracorporeal blood circuit.

### Claim 6 (depends on 1)

The blood purification device according to claim 1, wherein at least one additional measuring means for measuring a blood buffer parameter is associated with the control loop and is arranged in the dialysate outflow.